For a reliable diagnosis it is essential that analytical systems obtain accurate and consistent data. When diagnostic or blood screening laboratory acquires a new analytical instrument or installs a new software on existing instruments, they need to perform a validation of analytical system to achieve high-quality standards and to fulfill regulatory requirements. An overview of guidelines and literature can be found in the following documents:                Validation of analytical methods, Ludwig Huber, Agilent Technologies, 2010        Gen. principles of software validation; final guidance for industry and FDA staff, U.S. Department of Health and Human Services, FDA, 2002        
Depending on country specific regulations and laboratory standard operating procedures, the validation and verification of analytical systems represent a very expensive and time-consuming procedure. At the moment, diagnostic laboratories need either to buy additional instruments for this process or shutdown analytical testing until the new system is validated.